AcrySof™ IQ Vivity™ DFT315 (REF DFT315.180)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV and Blue Light Filtering Acrylic Foldable Aspheric Wavefront-Shaping Toric Posterior Chamber Intraocular Lenses · Class 3 · Implant
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652421607), received between Jun 23, 2021 and Jul 31, 2023 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Malposition of Device3
- Defective Device1
- Scratched Material1
Patient problems
- Visual Impairment2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Capsular Bag Tear1
- Eye Injury1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Visual Disturbances1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2023Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER THE IOL IMPLANTATION, A SCRATCH WAS FOUND ON THE IOL. THE INCISION WAS WIDENED TO 3 MM SO THAT THE IOL COULD BE EXPLANTED WITH FORCEPS. A NEW IMPLANTATION WAS PERFORMED WITHOUT COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS NO IMPAIRMENT TO THE PATIENT. THE INTRAOCULAR PRESSURE (IOP) 28MMHG BUT NO ACTION REQUIRED AS ON SECOND CHECK PRESSURE WAS BACK BELOW 20MMHG ON THE DAY OF SURGERY.
Patient problems: Eye Injury
MAUDE report 17424901 ↗MalfunctionJul 3, 2023Malposition of Device; Malposition of Device
A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED DISPLACEMENT OF THE LENS OF 180º TOGETHER WITH A SIGNIFICANT DECREASE IN VISUAL ACUITY. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: Visual Impairment
MAUDE report 17247643 ↗InjuryOct 21, 2022Defective Device; Defective Device
A NON HEALTHCARE PROFESSIONAL REPORTED THAT LENS WAS DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Capsular Bag Tear; Insufficient Information
MAUDE report 15650382 ↗MalfunctionAug 9, 2021Malposition of Device; Malposition of Device
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SIGNIFICANT IOL ROTATION WAS NOTED AT 1WEEK OF POST OPERATION. THE PATIENT IS HAPPY WITH VISION. NO SECONDARY INTERVENTION IS REQUIRED AT THIS STAGE. NO FURTHER INFORMATION IS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12293868 ↗InjuryJun 23, 2021Malposition of Device; Malposition of Device
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED IMPAIRED VISION ON THE SECOND DAY AFTER THE SURGERY. IT WAS OBSERVED THAT THE TORIC LENS WAS AT 34 DEGREES WHEN IT SHOULD HAVE BEEN AT AN AXIS ANGLE OF 94 DEGREES, THE POST-OP ASTIGMATISM WAS FOUND TO BE 1.75 WITH THE LENS ROTATING APPROXIMATELY 60 DEGREES CLOCKWISE. THE PATIENT UNDERWENT A SECOND SURGICAL PROCEDURE AND THE LENS WAS PLACED AT 94 DEGREES AXIS ANGLE AGAIN WITHOUT REMOVING THE LENS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Disturbances; Visual Impairment
MAUDE report 12051522 ↗
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- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens93 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens89 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens87 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens75 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens73 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens71 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.